NCT04305093

Brief Summary

Data from previously analyzed clinical samples tested by Precision Analytical, Inc. will be mined to identify and select samples from patients reporting hormone supplement use. Patient demographics (BMI, for example), different therapies and expected changes in hormone levels will be analyzed and hormone metabolite patterns will be compared. Samples will be deidentified prior to analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144,561

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

3.3 years

First QC Date

March 9, 2020

Last Update Submit

March 28, 2023

Conditions

Obesity; EndocrineHormone Disturbance

Keywords

CortisolCortisol metabolitesObesitytestosteroneestradiolHormone therapySleep disturbanceAging

Outcome Measures

Primary Outcomes (2)

  • BMI - weight and height will be combined to report BMI in kg/m2

    Relationship of BMI to cortisol production and clearance

    6 months

  • Urinary hormonal profile including concentrations of estrone, estradiol, estriol, alpha-pregnanediol, and beta-pregnanediol

    Determination of urine estrogen and progesterone metabolites in postmenopausal women receiving hormonal treatment

    6 months

Study Arms (1)

Precision Analytical patients

Individuals who had laboratory work completed at Precision Analytical and completed the associated questionnaire on symptoms and comorbidities.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals between the ages of 18 and 85 years with data in the Precision Analytical database

You may qualify if:

  • Had testing done at Precision Analytical between 2016 and 2019

You may not qualify if:

  • Varies by data analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Precision Analytical, Inc

McMinnville, Oregon, 97128, United States

Location

Related Publications (8)

  • Abraham SB, Rubino D, Sinaii N, Ramsey S, Nieman LK. Cortisol, obesity, and the metabolic syndrome: a cross-sectional study of obese subjects and review of the literature. Obesity (Silver Spring). 2013 Jan;21(1):E105-17. doi: 10.1002/oby.20083.

    PMID: 23505190BACKGROUND

  • DUNKELMAN SS, FAIRHURST B, PLAGER J, WATERHOUSE C. CORTISOL METABOLISM IN OBESITY. J Clin Endocrinol Metab. 1964 Sep;24:832-41. doi: 10.1210/jcem-24-9-832. No abstract available.

    PMID: 14216471BACKGROUND

  • Newman M, Pratt SM, Curran DA, Stanczyk FZ. Evaluating urinary estrogen and progesterone metabolites using dried filter paper samples and gas chromatography with tandem mass spectrometry (GC-MS/MS). BMC Chem. 2019 Feb 4;13(1):20. doi: 10.1186/s13065-019-0539-1. eCollection 2019 Dec.

    PMID: 31384769BACKGROUND

  • Pasquali R, Cantobelli S, Casimirri F, Capelli M, Bortoluzzi L, Flamia R, Labate AM, Barbara L. The hypothalamic-pituitary-adrenal axis in obese women with different patterns of body fat distribution. J Clin Endocrinol Metab. 1993 Aug;77(2):341-6. doi: 10.1210/jcem.77.2.8393881.

    PMID: 8393881BACKGROUND

  • Rask E, Olsson T, Soderberg S, Andrew R, Livingstone DE, Johnson O, Walker BR. Tissue-specific dysregulation of cortisol metabolism in human obesity. J Clin Endocrinol Metab. 2001 Mar;86(3):1418-21. doi: 10.1210/jcem.86.3.7453.

    PMID: 11238541BACKGROUND

  • Stimson RH, Andersson J, Andrew R, Redhead DN, Karpe F, Hayes PC, Olsson T, Walker BR. Cortisol release from adipose tissue by 11beta-hydroxysteroid dehydrogenase type 1 in humans. Diabetes. 2009 Jan;58(1):46-53. doi: 10.2337/db08-0969. Epub 2008 Oct 13.

    PMID: 18852329BACKGROUND

  • SZENAS P, PATTEE CJ. Studies on adrenocortical function in obesity. J Clin Endocrinol Metab. 1959 Mar;19(3):344-50. doi: 10.1210/jcem-19-3-344. No abstract available.

    PMID: 13631051BACKGROUND

  • Tomlinson JW, Finney J, Hughes BA, Hughes SV, Stewart PM. Reduced glucocorticoid production rate, decreased 5alpha-reductase activity, and adipose tissue insulin sensitization after weight loss. Diabetes. 2008 Jun;57(6):1536-43. doi: 10.2337/db08-0094. Epub 2008 Mar 13.

    PMID: 18340018BACKGROUND

MeSH Terms

Conditions

ObesityEndocrine System DiseasesParasomnias

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Mark Newman, MS

    Precision Analytical, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 12, 2020

Study Start

December 15, 2019

Primary Completion

March 28, 2023

Study Completion

March 28, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations

US(1)